AccessGUDID - DEVICE: SpeediCath Flex Coude (05708932017084)

GUDID

Device Identifier (DI) Information

Brand Name: SpeediCath Flex Coude
Version or Model: 28916
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 28916
Company Name: Coloplast A/S

Primary DI Number: 05708932017084
Issuing Agency: GS1
Commercial Distribution End Date: June 18, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: Ready to use male catheter. Sterile urinary catheter for intermittent catheterization.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45603	Single-administration urethral drainage catheter	A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBM	CATHETER, URETHRAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 16 French
Length: 44 Centimeter
Outer Diameter: 5.3 Millimeter
Device Size Text, specify: Male
Length: 17.32 Inch

Device Record Status

Public Device Record Key: 32dd557f-c3cd-479f-ac58-9deaabf7a559
Public Version Date: June 19, 2020
Public Version Number: 4
DI Record Publish Date: November 04, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05708932643665	3	05708932017213	2020-06-18	Not in Commercial Distribution	shipper box
05708932017213	30	05708932017084	2020-06-18	Not in Commercial Distribution	retail box